• Is responsible for the hiring, training, development and retention of a team of CRAs to deliver quality monitoring to the Phase I-IV trials
• Performs ongoing assessment and allocation of monitoring resources to ensure balanced workload for quality monitoring
• Ensures CRAs have the required level of Monitoring area knowledge and skills to successfully deliver to protocol and study requirements
• Is responsible for managing and addressing CRA performance and quality performance indicators, including managing timely site activation, recruitment commitments, timely data entry and issue resolution and appropriate application of established Monitoring procedures and tools in accordance with GCP, ICH, SOP’s, and local regulations.
• Adheres to and contributes to the development and review of Working Instructions and SOPs, if required

• Allocate CRA resource (including FSP staff if appliable) in new and ongoing trials in collaboration with Clinical Monitoring teams.
• Ensures trial site selection, activation, enrolment, data flow and timeline commitments are delivered per established Monitoring Key Performance Indicator trial objectives.
• In collaboration with CSMs/PMs, reviews the status of planned versus actual site start-up, patient recruitment and supports implementation of strategies to correct deviations from proposed plan
• Enhance Bei Gene relationship with clinical sites, to ensure site performance to trial commitments and delivery of quality monitoring

• Is accountable for monitoring quality and issue resolution through support of study monitoring visit report review to ensure quality trial oversight and appropriate issue escalation/resolution
• Ensures CRA competency gaps are identified and resolved through targeted training curricula in collaboration with local trainer
• Is responsible for execution of assessment visits (where required) to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies
• Performs accompanied visits, if required
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Supports site audits and inspection and ensures CAPA follow-up and implementation for monitor and site identified issues
• Manages CRA adherence/compliance to SOPs and required training curricula

• Bachelors degree or higher in a scientific or healthcare discipline preferred
• 1 year or above of people management in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
• Solid understanding of career development and performance management activities
• Evidence of team leadership and engagement capabilities
• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
• Therapeutic or medical knowledge preferred
• Understanding of all aspects of monitoring and trial execution
• Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (CNDA), local/National Health Authorities regulations and Bei Gene standards

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity